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REFERENCE CODE GDME1014FPR | PUBLICATION DATE SEPTEMBER 2013
DRUG-ELUTING BALLOONS – CURRENT AND FUTURE PLAYERS
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DRUG-ELUTING BALLOONS – CURRENT AND FUTURE PLAYERS
Table of Contents
1 Table of Contents
1 Table of Contents ...................................................................................................................... 2
1.1 List of Tables ........................................................................................................................ 6
1.2 List of Figures ..................................................................................................................... 11
2 Introduction ............................................................................................................................. 12
2.1 Catalyst ............................................................................................................................... 13
2.2 Related Reports .................................................................................................................. 14
3 Competitive Assessment ......................................................................................................... 15
3.1 Overview ............................................................................................................................. 15
3.2 Product Profiles by Company .............................................................................................. 17
3.2.1 Aachen Resonance ........................................................................................................ 18
3.2.2 B. Braun ......................................................................................................................... 20
3.2.3 Biotronik ......................................................................................................................... 27
3.2.4 Blue Medical ................................................................................................................... 30
3.2.5 Cardionovum .................................................................................................................. 36
3.2.6 C.R. Bard ........................................................................................................................ 41
3.2.7 Concept Medical Research ............................................................................................. 47
3.2.8 Cook Medical .................................................................................................................. 51
3.2.9 Eurocor ........................................................................................................................... 53
3.2.10 Medrad (Bayer Healthcare) ............................................................................................. 68
3.2.11 Medtronic ........................................................................................................................ 70
3.2.12 Minvasys ........................................................................................................................ 78
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Table of Contents
4 Pipeline Products .................................................................................................................... 81
4.1 Overview ............................................................................................................................. 81
4.2 Pipeline by Stage of Development ...................................................................................... 82
4.3 Pipeline Product Profiles ..................................................................................................... 84
4.3.1 NF-κB Decoy Oligo DEB ................................................................................................. 84
4.3.2 Drug-Coated AngioSculpt ............................................................................................... 86
4.3.3 BioPath ........................................................................................................................... 89
4.3.4 BioStream ....................................................................................................................... 90
4.3.5 Boston Scientific Drug-Coated Balloon ........................................................................... 91
4.3.6 Coroflex DEBlue ............................................................................................................. 92
4.3.7 Covidien Drug-Coated Balloon........................................................................................ 94
4.3.8 DSM Biomedical and Caliber Therapeutics DEB............................................................. 96
4.3.9 Elixir Medical Corporation DCB....................................................................................... 97
4.3.10 LifeTech Scientific Corporation DEB ............................................................................... 97
4.3.11 Micell Technologies Drug-Coated Balloon ...................................................................... 97
4.3.12 Drug-Coated Chocolate DEB .......................................................................................... 99
4.3.13 Passeo-18 Lux .............................................................................................................. 101
4.3.14 Vascular Nanotransfer Technologies Drug-Coated Balloon .......................................... 102
4.3.15 WOMBAT DCB ............................................................................................................. 103
5 Current and Future Players ................................................................................................... 105
5.1 Overview ........................................................................................................................... 105
5.2 Trends in Corporate Strategy ............................................................................................ 106
5.3 Company Profiles .............................................................................................................. 109
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Table of Contents
5.3.1 Aachen Resonance ...................................................................................................... 109
5.3.2 AnGes MG .................................................................................................................... 110
5.3.3 AngioScore ................................................................................................................... 112
5.3.4 AVIDAL Vascular .......................................................................................................... 114
5.3.5 B. Braun ....................................................................................................................... 116
5.3.6 Biosensors International ............................................................................................... 118
5.3.7 Biotronik ....................................................................................................................... 120
5.3.8 Blue Medical ................................................................................................................. 122
5.3.9 Boston Scientific Corporation ........................................................................................ 124
5.3.10 Caliber Therapeutics ..................................................................................................... 126
5.3.11 Cardionovum ................................................................................................................ 128
5.3.12 Concept Medical Research ........................................................................................... 130
5.3.13 Cook Medical ................................................................................................................ 132
5.3.14 Covidien ....................................................................................................................... 134
5.3.15 C.R. Bard ...................................................................................................................... 136
5.3.16 DSM Biomedical ........................................................................................................... 138
5.3.17 Elixir Medical Corporation ............................................................................................. 140
5.3.18 Eurocor ......................................................................................................................... 142
5.3.19 LifeTech Scientific Corporation ..................................................................................... 144
5.3.20 Medtronic ...................................................................................................................... 146
5.3.21 Micell Technologies ...................................................................................................... 148
5.3.22 Minvasys ...................................................................................................................... 149
5.3.23 TriReme Medical........................................................................................................... 151
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Table of Contents
5.3.24 Vascular Nanotransfer Technologies ............................................................................ 153
6 Appendix ............................................................................................................................... 155
6.1 Bibliography ...................................................................................................................... 155
6.2 Abbreviations .................................................................................................................... 165
6.3 Report Methodology .......................................................................................................... 168
6.3.1 Overview ...................................................................................................................... 168
6.3.2 Coverage ...................................................................................................................... 168
6.3.3 Secondary Research .................................................................................................... 169
6.3.4 Forecasting Methodology.............................................................................................. 169
6.4 Physicians and Specialists Included in this Study ............................................................. 171
6.5 Physician Survey .............................................................................................................. 174
6.6 About the Authors ............................................................................................................. 175
6.6.1 Analysts ........................................................................................................................ 175
6.6.2 Global Head of Healthcare ............................................................................................ 176
6.7 About MediPoint ................................................................................................................ 177
6.8 About GlobalData .............................................................................................................. 177
6.9 Disclaimer ......................................................................................................................... 177
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Table of Contents
1.1 List of Tables
Table 1: Global DEB Market ($m) for Treating Coronary and Peripheral Artery Disease, 2012 ....................... 15
Table 2: Marketed DEB Products ................................................................................................................... 17
Table 3: Elutax SV Product Portfolio .............................................................................................................. 18
Table 4: Elutax SV SWOT Analysis, 2013 ...................................................................................................... 20
Table 5: SeQuent Please Product Portfolio .................................................................................................... 21
Table 6: SeQuent Please SWOT Analysis, 2013 ............................................................................................ 26
Table 7: Pantera Lux Product Portfolio ........................................................................................................... 27
Table 8: Pantera Lux SWOT Analysis, 2013 .................................................................................................. 29
Table 9: Pioneer Product Portfolio ................................................................................................................. 30
Table 10: Pioneer SWOT Analysis, 2013 ....................................................................................................... 32
Table 11: Protégé Product Portfolio ............................................................................................................... 33
Table 12: Protégé SWOT Analysis, 2013 ....................................................................................................... 36
Table 13: Restore DEB Product Portfolio ....................................................................................................... 37
Table 14: Restore DEB SWOT Analysis, 2013 ............................................................................................... 38
Table 15: Legflow DEB Product Portfolio ....................................................................................................... 39
Table 16: Legflow DEB SWOT Analysis, 2013 ............................................................................................... 41
Table 17: Lutonix Product Portfolio ................................................................................................................ 42
Table 18: Lutonix SWOT Analysis, 2013 ........................................................................................................ 47
Table 19: Magic Touch Product Portfolio ........................................................................................................ 48
Table 20: Magic Touch SWOT Analysis, 2013 ............................................................................................... 50
Table 21: Advance 18 PTX Product Portfolio ................................................................................................. 51
Table 22: Advance 18 PTX SWOT Analysis, 2013 ......................................................................................... 53
Table 23: Dior Product Portfolio ..................................................................................................................... 54
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Table of Contents
Table 24: Dior SWOT Analysis, 2013 ............................................................................................................. 60
Table 25: Freeway Family of DEB Product Portfolio ....................................................................................... 61
Table 26: Freeway Family of DEB SWOT Analysis, 2013 ............................................................................... 64
Table 27: Magical Product Portfolio................................................................................................................ 65
Table 28: Magical SWOT Analysis, 2013 ....................................................................................................... 67
Table 29: Cotavance Product Portfolio ........................................................................................................... 68
Table 30: Cotavance SWOT Analysis, 2013................................................................................................... 70
Table 31: IN.PACT Family DEB Product Portfolio .......................................................................................... 71
Table 32: IN.PACT SWOT Analysis, 2013 ..................................................................................................... 78
Table 33: Danubio Product Portfolio............................................................................................................... 79
Table 34: Danubio SWOT Analysis, 2013 ...................................................................................................... 80
Table 35: Global DEB Pipeline Products ........................................................................................................ 83
Table 36: NF-κB Decoy Oligo DEB SWOT Analysis, 2013 ............................................................................. 86
Table 37: AngioSculpt SWOT Analysis, 2013 ................................................................................................. 88
Table 38: BioPath SWOT Analysis, 2013 ....................................................................................................... 90
Table 39: BioStream SWOT Analysis, 2013 ................................................................................................... 91
Table 40: Boston Scientific DEB SWOT Analysis, 2013 ................................................................................. 92
Table 41: Coroflex DEBlue SWOT Analysis, 2013.......................................................................................... 94
Table 42: Covidien DCB SWOT Analysis, 2013 ............................................................................................. 96
Table 43: Micell Technologies’ DCB SWOT Analysis, 2013 ............................................................................ 98
Table 44: Drug-Coated Chocolate DEB SWOT Analysis, 2013 ..................................................................... 100
Table 45: Passeo-18 Lux SWOT Analysis, 2013 .......................................................................................... 102
Table 46: Vascular Nanotransfer Technologies DCB SWOT Analysis, 2013 ................................................. 103
Table 47: WOMBAT DCB SWOT Analysis, 2013 ......................................................................................... 104
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Table of Contents
Table 48: Aachen Resonance Company Profile ........................................................................................... 109
Table 49: Aachen Resonance, Marketed DEB Product ................................................................................ 110
Table 50: Aachen Resonance SWOT Analysis, 2013 ................................................................................... 110
Table 51: AnGes MG Company Profile ........................................................................................................ 111
Table 52: AnGes MG, Pipeline DEB Product ................................................................................................ 112
Table 53: AnGes MG SWOT Analysis, 2013 ................................................................................................ 112
Table 54: AngioScore Company Profile........................................................................................................ 113
Table 55: AngioScore, Pipeline DEB Product ............................................................................................... 113
Table 56: AngioScore SWOT Analysis, 2013 ............................................................................................... 114
Table 57: AVIDAL Vascular Company Profile ............................................................................................... 114
Table 58: AVIDAL Vascular, Pipeline DEB Product ...................................................................................... 115
Table 59: AVIDAL Vascular SWOT Analysis, 2013 ...................................................................................... 116
Table 60: B. Braun Company Profile ............................................................................................................ 116
Table 61: B. Braun, Marketed and Pipeline DEB Products ........................................................................... 117
Table 62: B. Braun SWOT Analysis, 2013 .................................................................................................... 118
Table 63: Biosensors International Company Profile .................................................................................... 119
Table 64: Biosensors International, Pipeline DEB Products .......................................................................... 119
Table 65: Biosensors International SWOT Analysis, 2013 ............................................................................ 120
Table 66: Biotronik Company Profile ............................................................................................................ 121
Table 67: Biotronik, Marketed and Pipeline DEB Products ........................................................................... 121
Table 68: Biotronik SWOT Analysis, 2013 .................................................................................................... 122
Table 69: Blue Medical Company Profile ...................................................................................................... 123
Table 70: Blue Medical, Marketed DEB Products ......................................................................................... 124
Table 71: Blue Medical SWOT Analysis, 2013 ............................................................................................. 124
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Table of Contents
Table 72: Boston Scientific Corporation Company Profile ............................................................................. 125
Table 73: Boston Scientific Corporation, Pipeline DEB Product .................................................................... 125
Table 74: Boston Scientific Corporation SWOT Analysis, 2013 .................................................................... 126
Table 75: Caliber Therapeutics Company Profile ......................................................................................... 126
Table 76: Caliber Therapeutcs, Pipeline DEB Product.................................................................................. 127
Table 77: Caliber Therapeutics SWOT Analysis, 2013 ................................................................................. 128
Table 78: Cardionovum Company Profile ..................................................................................................... 128
Table 79: Cardionovum, Marketed DEB Products ........................................................................................ 129
Table 80: Cardionovum SWOT Analysis, 2013............................................................................................. 130
Table 81: Concept Medical Research Company Profile ................................................................................ 130
Table 82: Concept Medical Research, Marketed DEB Product ..................................................................... 131
Table 83: Concept Medical Research SWOT Analysis, 2013 ....................................................................... 132
Table 84: Cook Medical Company Profile .................................................................................................... 132
Table 85: Cook Medical, Marketed DEB Product .......................................................................................... 133
Table 86: Cook Medical SWOT Analysis, 2013 ............................................................................................ 134
Table 87: Covidien Company Profile ............................................................................................................ 135
Table 88: Covidien, Pipeline DEB Product ................................................................................................... 135
Table 89: Covidien SWOT Analysis, 2013 .................................................................................................... 136
Table 90: C.R. Bard Company Profile .......................................................................................................... 136
Table 91: C.R. Bard, Marketed DEB Products .............................................................................................. 137
Table 92: C.R. Bard SWOT Analysis, 2013 .................................................................................................. 138
Table 93: DSM Biomedical Company Profile ................................................................................................ 139
Table 94: DSM Biomedical, Pipeline DEB Product ....................................................................................... 139
Table 95: DSM Biomedical SWOT Analysis, 2013........................................................................................ 140
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Table of Contents
Table 96: Elixir Medical Corporation Company Profile .................................................................................. 140
Table 97: Elixir Medical Corporation, Pipeline DEB Product ......................................................................... 141
Table 98: Elixir Medical Corporation SWOT Analysis, 2013 .......................................................................... 141
Table 99: Eurocor Company Profile ............................................................................................................. 142
Table 100: Eurocor, Marketed DEB Products ............................................................................................... 143
Table 101: Eurocor SWOT Analysis, 2013 ................................................................................................... 143
Table 102: LifeTech Scientific Corporation Company Profile ........................................................................ 144
Table 103: LifeTech Scientific, Pipeline DEB Product ................................................................................... 145
Table 104: LifeTech Scientific SWOT Analysis, 2013 ................................................................................... 145
Table 105: Medtronic Company Profile ........................................................................................................ 146
Table 106: Medtronic, Marketed DEB Products ............................................................................................ 147
Table 107: Medtronic SWOT Analysis, 2013 ................................................................................................ 147
Table 108: Micell Technologies Company Profile ......................................................................................... 148
Table 109: Micell Technologies, Pipeline DEB Product ................................................................................ 149
Table 110: Micell Technologies SWOT Analysis, 2013 ................................................................................. 149
Table 111: Minvasys Company Profile ......................................................................................................... 150
Table 112: Minvasys, Marketed DEB Product .............................................................................................. 150
Table 113: Minvasys SWOT Analysis, 2013 ................................................................................................. 151
Table 114: TriReme Medical Company Profile ............................................................................................. 151
Table 115: TriReme Medical, Pipeline DEB Product ..................................................................................... 152
Table 116: TriReme Medical SWOT Analysis, 2013 ..................................................................................... 153
Table 117: Vascular Nanotransfer Technologies Company Profile ............................................................... 153
Table 118: Vascular Nanotransfer Technologies, Pipeline DEB Product ....................................................... 154
Table 119: Vascular Nanotransfer Technologies SWOT Analysis, 2013 ....................................................... 154
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DRUG-ELUTING BALLOONS – CURRENT AND FUTURE PLAYERS
Table of Contents
Table 120: Physicians Surveyed, By Country ............................................................................................... 174
1.2 List of Figures
Figure 1: Global DEB Market Share for Treating Peripheral Artery Disease in the Lower Extremity, 2012 ... 16
Figure 2: Image of the Protégé DEB........................................................................................................... 34
Figure 3: Global DEB Pipeline Products by Stage of Development, 2013 ................................................... 82
Figure 4: AngioSculpt Scoring Balloon Expansion Profile ........................................................................... 87
Figure 5: Drug-Coated Chocolate DEB ...................................................................................................... 99
Figure 6: DEB Market for Treating CAD and PAD in the Lower Extremity, Company Share (%), 2012 ...... 105
Figure 7: DEB Market for Each Type of Disease, Company Share (%), 2012 ........................................... 107
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DRUG-ELUTING BALLOONS – CURRENT AND FUTURE PLAYERS
Introduction
2 Introduction
Coronary artery disease (CAD) and peripheral artery disease (PAD) are global public health and
socioeconomic issues that affect millions of lives each year. Percutaneous coronary interventions
(PCI) and endovascular therapies, such as stenting and angioplasty, have been widely adopted to
treat CAD and PAD in the lower extremity. Vascular stents, such as bare metal and drug-eluting
stents are often used in clinical practice to treat coronary and peripheral artery lesions. However,
for indications such as in-stent restenosis (ISR), small-vessel disease, coronary bifurcations, and
femoropopliteal artery and below-the-knee (BTK) lesions, stenting is associated with poor clinical
outcomes, reiterating the need for alternative therapies. In addition, implanting permanent stents,
such as drug-eluting stents (DES) and bare metal stents (BMS), into the vessel can increase the
risk of chronic inflammation, restenosis, and thrombosis.
Emerging technologies, such as drug-eluting balloons (DEB), address the challenges and
complications of stenting in these subsets of lesions. DEB provide fast, short-term, homogenous,
local drug delivery, preserve the anatomy of the vessel, promote enhanced vessel healing, and
reduce the need for prolonged dual antiplatelet therapy without leaving any metal behind. Medical
device companies have developed a range of DEB for coronary and peripheral applications in the
lower extremity. The majority of these DEB have paclitaxel as the antiproliferative drug of choice,
with different drug coating technologies and balloon/catheter designs. In this report, DEB are
defined as drug-coated angioplasty balloon catheters.
This report focuses on the global DEB market for treating CAD and PAD in the lower extremity. The
global DEB market is determined for the 10 countries covered in the report, which are the US,
France, Germany, Italy, Spain, the UK, Japan, Brazil, China, and India. The report identifies and
analyzes the key companies shaping and driving the global DEB market. The report provides
insight into the competitive DEB landscape, including new companies entering the market and
pipeline products in development. From GlobalData’s analysis, it is evident that the current
adoption of DEB for coronary and peripheral applications is slow. However, the DEB market for
peripheral applications is larger compared with that for coronary applications. DEB are currently not
commercially available in the US or Japan. Large-scale, long-term, cost-effectiveness studies need
to be conducted to demonstrate their clinical efficacy and DEB need to be integrated appropriately
into the existing reimbursement systems.
DEB provide fast, short-term, homogenous, local drug delivery, preserve the anatomy of the vessel, promote enhanced vessel healing, and reduce the need for prolonged dual antiplatelet therapy without leaving any metal behind
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DRUG-ELUTING BALLOONS – CURRENT AND FUTURE PLAYERS
Introduction
To successfully market DEB, companies need to design novel platforms that address the
challenges in treating femoropopliteal and infrapopliteal artery lesions, coronary bifurcations, and
small-vessel disease, and show that they have superior clinical performance to the stents that are
used to treat these lesions.
2.1 Catalyst
Minimally-invasive techniques, including stenting and angioplasty, have become the standard of
care for patients with CAD and PAD in the lower extremity. Modern developments in endovascular
interventions have led to a paradigm shift in the treatment of PAD in the lower extremity towards
endovascular therapy. Although vascular stents, including bare metal, drug-eluting, and covered
stents, offer treatment solutions for patients, they do not provide sustained clinical outcomes in
lesions such as ISR, small-vessel disease, coronary bifurcations, and superficial femoral artery
(SFA) and BTK lesions. In the peripheral vasculature, the femoropopliteal and infrapopliteal arteries
are challenging to treat, given the diffuse nature of the atherosclerotic disease and long and
heavily-calcified lesions. In the femoropopliteal arteries, the high plaque burden, slow vascular flow,
and exposure to high mechanical forces increase the risk of stent compression and fracture.
Alternative effective technologies need to be designed to address these unmet needs.
Compared with the coronary and peripheral vascular stent markets, the DEB market is a much
smaller market. However, it is a dynamic market that allows device manufacturers to develop a
range of platforms to target different coronary and peripheral indications. Low-profile DEB
technologies are being developed to reduce the risk of complications of stenting such as restenosis
and thrombosis, improve long-term vessel patency, and reduce barotrauma to the vessel. DEB-
only and DEB as an adjunct therapy can be used to treat complex and challenging lesions and
optimize stenting. Given the lack of effective therapies, DEB can become the gold standard of
treatment for coronary/peripheral artery ISR. In addition, DEB may become a primary therapy for
treating peripheral lesions in the lower extremity, where stenting can be used as a “bailout”
strategy.
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DRUG-ELUTING BALLOONS – CURRENT AND FUTURE PLAYERS
Introduction
As more long-term clinical data that demonstrate the superior therapeutic benefits of DEB and
reimbursement become available, the adoption of DEB by the medical community will increase
slowly in the future. As CAD and PAD present enormous global public health and socioeconomic
issues, and use of stents continues to increase, it is important to find effective treatment modalities
that ensure long-term quality results for patients.
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DRUG-ELUTING BALLOONS – CURRENT AND FUTURE PLAYERS
Appendix
6.7 About MediPoint
MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built
from the ground up by our team of healthcare analysts in the US and UK. Each report includes
input from experienced physicians and leading key opinion leaders (KOLs). Running throughout
each report in the series, “What Physicians Think” quotes provide a unique insight into how
healthcare professionals are reacting to events within the industry, and what their responses could
mean for industry strategists.
6.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports, and
forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has
offices in New York, Boston, London, India, and Singapore.
6.9 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior
permission of the publisher, GlobalData.